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Trial record 1 of 1 for:    NCT02993861
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Pharmacokinetics of Anti-epileptic Drugs in Obese Children

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ClinicalTrials.gov Identifier: NCT02993861
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Information provided by (Responsible Party):
Christoph P Hornik, MD MPH, Duke University

Brief Summary:
The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).

Condition or disease Intervention/treatment
Epilepsy Obese Other: Anti-epileptics

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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Actual Study Start Date : December 9, 2016
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Levetiracetam
Children with epilepsy who are treated with levetiracetam per local standard of care
Other: Anti-epileptics
Valproic Acid
Children with epilepsy who are treated with valproic acid per local standard of care
Other: Anti-epileptics
Topiramate
Children with epilepsy who are treated with topiramate per local standard of care
Other: Anti-epileptics
Oxcarbazepine
Children with epilepsy who are treated with oxcarbazepine per local standard of care
Other: Anti-epileptics



Primary Outcome Measures :
  1. Steady-state pharmacokinetics area under the curve [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  2. Steady-state pharmacokinetics maximum concentration [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  3. Steady-state pharmacokinetics time to reach maximum concentration [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  4. Steady-state pharmacokinetics oral apparent volume of distribution [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  5. Steady-state pharmacokinetics half life [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  6. Steady-state pharmacokinetics oral apparent clearance [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]
  7. Steady-state pharmacokinetics absorption rate constant [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]

Secondary Outcome Measures :
  1. Serious adverse events [ Time Frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.
Criteria

Inclusion Criteria:

  • 2 years to < 18 years at the time of enrollment
  • BMI ≥ 95th percentile for age and sex, based on CDC recommendations
  • Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)
  • Receiving ≥ 1 of the study drugs per local standard of care

Exclusion Criteria:

  • Known pregnancy as determined via interview or test results, if available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993861


Locations
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United States, Colorado
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Delaware
Nemours Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Georgia
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States, 30324
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Kentucky
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States, 40202
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Duke University Health System
Durham, North Carolina, United States, 27705
Coastal Children's Services
Wilmington, North Carolina, United States, 28401
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Texas
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, United States, 75390-8589
Sponsors and Collaborators
Christoph P Hornik, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Investigators
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Principal Investigator: Kanecia Zimmerman, MD, MPH Duke Medical Center/Duke Clinical Research Institute
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Responsible Party: Christoph P Hornik, MD MPH, Associate Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT02993861    
Other Study ID Numbers: Pro00070924
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Christoph P Hornik, MD MPH, Duke University:
Epilepsy
Obese
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants